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1.26 PI Qualifications and Responsibilities

Last Revised: 6/27/202211/2025

1.0 Purpose

The purpose of this policy and procedure is to describe the qualifications and responsibilities of the PI during the conduct of research within the Organization and at external sites under the PI’s protocol.research.

2.0 Policy

It is the policy of the Organization that

  • 2.1. The PI must be an employee, faculty, or student of the Organization. Faculty shall include full- or part-time persons or emeritus faculty.
  • 2.2. The PI must be qualified by education, training, experience and alllicensure other(as personnel involved in the conduct of research must possess the required experience, skill, and appropriate medical licensureapplicable) to safely conduct the research in full compliance with all applicable regulatory and Organizational requirements specified in HRPP policy 1.1 (Human Research Protection Program).

    , and in this policy.

3.0 Definitions

  • 3.1. Investigator is defined broadly by the Organization as an individual who actually conducts human subject research as either a Principal Investigator (PI) or a Secondary Investigator (SI).

    Investigator

      is not specifically defined by HHS regulations. However,
    • 3.1.1. HHS guidance defines “investigator” as the individual performing various tasks related to the conduct of human subject research activities, such as obtaining informed consent from subjects, interacting with subjects, and communicating with the IRB. For the purposes of the HHS regulations, OHRP interprets an “investigator” to be any individual who is involved in conducting human subjectsubjects research.research studies. Such involvement would include:

      include
        (1)
      • 3.1.1. Obtainingobtaining information about living individuals by intervening or interacting with them for research purposes.
        • purposes;
      • (2) 3.1.2. Obtainingobtaining identifiable private information about living individuals for research purposes.
        • purposes;
      • (3) 3.1.3. Obtainingobtaining the voluntary informed consent of individuals to be subjects in research.
        • research;
      • or 3.1.4.(4) Studying,studying, interpreting, or analyzing identifiable private information or data for research purposes.
      • 3.1.2. FDA regulation defines investigator as “an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject)” (21 CFR 312.3), or as a person “responsible for ensuring that an investigation is conducted according to the signed agreement, the investigational plan and applicable FDA regulations, for protecting the rights, safety, and welfare of subjects under the investigator's care, and for the control of devices under investigation” (21 CFR 812.100)

    • 3.2. Principal Investigator (PI) is the individual under whose direction the research is conducted and who assumes overall responsibility for the safe and proper conduct of the research (single or multi-site) in full compliance with allthe applicableprotocol, regulationsHRPP policies, IRB requirements, Federal regulations, and UNMCstate HRPPlaw. policies.

      • 3.2.1. For multi-institutional studies in which the Organization is a participating site, PI refers to the UNMC/NM, UNO or CN investigator under whose direction the research is conducted at this organization. If the Lead PI (who has overall responsibility for research conducted at all participating sites) is at another institution, they are not subject to this policy.

    • 3.3. Secondary Investigator (SI) is an individual who shares responsibility with the PI for the safe and proper conduct of the research in full compliance with allthe applicableprotocol, regulationsHRPP policies, IRB requirements, Federal regulations, and UNMCstate HRPP policies.

      law.

    • 3.4. ExternalResearch Investigatorpersonnel (XI)are is an investigator who is not employed by or otherwise representing the Organization who is engageddefined in research for which the UNMC IRB is the IRB of record.

      A researcher employed or otherwise representing another institution who is under the jurisdiction of another IRB which has a reliance agreement with UNMC and for which the UNMC is acting as a central or single IRB is NOT considered an XI (per HRPP policy 1.2827; External(Research InvestigatorPersonnel Assurance)Qualifications and Responsibilities).

    • 3.5. Investigational New Drug is a new drug or biologic that is used in a clinical investigation (21 CFR 312.3(b))

    • 3.6. Investigation New Drug Application (IND) is an application submitted to FDA to conduct a clinical investigation with an investigational new drug.

    • 3.7. Investigational Device is a device, including a transitional device, which is the object of the investigation.

    • 3.8. Investigational Device Exemption (IDE) is an application submitted to FDA to conduct a clinical investigation with an investigational device that is classified as a significant risk device (SRD).

      device.

    • 3.9. Sponsor-Investigator is the individual, who initiates the research, assumes overall responsibility for the research as indicated in section 3.2 above and also fulfills the FDA-required responsibilities of a sponsor.

    • 3.10. External Investigator Assurance (XIA) is an assurance of compliance which must be completed by all XIs when the UNMC IRB is the IRB of record.

    4.0 QualificationPI Requirements for the PIQualifications

    • 4.1. The PI must be an employee, faculty, or student of the Organization. Faculty shall include full- or part-time persons or emeritus faculty. Faculty includeincludes volunteer faculty (those with special faculty appointments, such as volunteer, adjunct, courtesy (without a UNMC faculty appointment), research or visiting faculty (collectively referred to as “volunteer faculty”)faculty).
      • 4.1.1. Volunteer faculty may serve as PI only with the written permission of the appropriate UNMC or UNO Dean or his/herDirector designee.(or their designee). The UNMC or UNO Dean or Director may, at his or hertheir discretion, place additional requirements (such as the concurrent approval of a department chairperson). The UNMC or UNO Dean or designeeDirector must accept ultimate responsibility tofor assuring the PI fulfills his/hertheir responsibilities under this policy.
      • 4.1.2. If the research involves any direct contact with human subjects on the facilitiespremises of the Organization, then volunteer faculty serving as PI must be present physically on the facilitiespremises of the Organization, or have a secondary investigator who is UNMC or UNO faculty present physically on the facilities,premises, to allow them to conduct and oversee research activities.
      • 4.1.3. Volunteer faculty may not serve as PI on a protocol which requires review and approval of the Institutional Biosafety Committee.
    • 4.1.4.2. Medical or dental practitioners or other allied health practitioners who have admitting privileges but do not have a faculty appointment as above may not serve as PI.
  • 4.2.3. Individuals other than employee, faculty, or student of the Organization may serve as PI only if a special memorandum of understanding exists between the Organization and another entity which sponsors that individual and that research (for example, faculty of University of Nebraska Lincoln for FDA regulated research, or faculty of National Strategic Research Institute).
    • 4.4. 4.2.1. When aA student or trainee is(including residents and graduate students) of the PI,Organization may serve as PI only if a researcherfaculty member sufficiently experienced in the area of the trainee’s research interest and satisfying the requirements of Section 4.1 above mustalso serveserves as a co-secondary investigator for research and befaculty advisor, and is jointly responsible for oversight of the research.
      • The responsibilities of the Faculty Advisor are described in HRPP policy 1.27 (Research Personnel Qualifications and Responsibilities).
      • 4.2.2.4.1. A student or trainee may not serve as the PI of a study which involves the administration or use of an FDA regulated drug, device or biologic.
    • 4.3.5. The PI must be qualified by education, training, experience and licensure (as applicable) to assume overall responsibility for the safe and proper conduct of the research in full compliance with allthe applicableprotocol, regulationsHRPP policies, IRB requirements, Federal regulations, and UNMCstate HRPP policies.
      • 4.3.1. When a student or trainee is the PI, a researcher sufficiently experienced in the area of the trainee’s research interest and satisfying the requirements of Section 4.1 above must serve as a co-investigator for research and be jointly responsible for oversight of the research.
      • 4.3.2. A student may not serve as the PI of a study which involves the administration or use of an FDA regulated drug, device or biologic.
      law.

    5.0 Responsibilities of the PI During the Conduct of Research

    • 5.1. The PI will conduct protocols with sound research design consistent with currentscientific, methodsethical and ethicalregulatory standards. TheWhen appropriate, the PI will seek independent review and consultation by other experts prior to submission to the IRBIRB. when

        appropriate.

        Note:

      • 5.1.1. Research designed and conducted by students and trainees as PI must be thoroughly reviewed by the faculty advisoradvisor.
        • and exhibit sound research design.

    • 5.2. The PI is responsible for obtaining IRB approval (or exempt determination) prior to initiating the research. Documentation of this approval must be written and dated.

    • 5.3. The PI is responsible for conducting research in compliance with the detailed protocol, the IRB application, and any other documents approved by the IRB.

    • 5.4. The PI will ensure compliance with applicable regulatory and HRPP requirements specified in HRPP policy 1.1 (Human Research Protection Program).

    • 5.5. The PI must oversee and be responsible for ensuring all research personnel comply with all applicable requirements, including, but not limited to, implementing the research in accordance with the IRB-approved protocol and completing all educational requirements as specified in HRPP policy 1.23 (HRPP Training Requirements and Opportunities for Research Personnel).

    • 5.6. The PI is responsible for ensuring that research is conducted in accordance with the terms of any grant, contract, and/or signed agreement.

    • 5.6.

      The PI must oversee and be responsible for ensuring all research personnel comply with all applicable regulatory and HRPP requirements.

    • 5.7. The PI will ensure all secondary investigators (sub-investigators) and other studyresearch personnel conducting the research are qualified by education, training, experience, and medical licensure (as applicable) to safely conduct the research in full compliance with the applicableprotocol, federalHRPP policies, IRB requirements, Federal regulations, HRPP policies and thestate protocol.

      law.

    • 5.8. The PI willis provideresponsible to ensure all secondaryresearch investigator(s)personnel conductinghave thecompleted researchall educational requirements as specified in HRPP policy 1.23 (HRPP Training Requirements and otherOpportunities studyfor personnelResearch (as appropriate) with a copy of the: a) UNMC IRB-approved application and ICF(s)/information sheet(s), b) detailed protocol, c) Investigator’s Brochure, and d) other necessary documents.

      Personnel).

    • 5.9. The PI will ensure that all secondary investigator(s) and other studyresearch personnel fully understand the study and their obligations consistent with assigned responsibilities.

    • 5.10. The PI will ensure all research personnel have access to (1) the IRB-approved application and informed consent documents/information sheets; (2) the detailed protocol; (3) the Investigator’s Brochure (as appropriate); and (4) other documents necessary to safely conduct the research.

    • 5.11. The PI will disclose, and assureensure that responsible personnel and other covered persons disclose potential financial COI, in accordance with HRPP policy 1.25 (Financial Conflicts of Interest) and Organizational policies.

    • 5.11.12. The PI will ensure risks to subjects and others have been minimized to the greatest extent possible, as per HRPP policy 3.2 (Data and Safety Monitoring).

    • 5.12.13. The PI will ensure the protocol contains a plan for just, fair, and equitable recruitment and selection of subjects.

    • 5.13.14. The PI will ensure the protocol contains adequate provisions for monitoring the data collected to ensure the safety of subjects.

    • 5.14.15. The PI will ensure there are adequate provisions to protect the privacy of subjects and the confidentiality of data, as per HRPP policy 3.3 (Privacy Interests and Confidentiality of Research Data).

    • 5.15.16. The PI will ensure there are adequate resources to carry out the research safely. This includes, but is not limited to, sufficient investigator time, appropriately qualified research team members, equipment and space.

    • 5.16.17. The PI may not make any changes in the research without IRB approval, except in accordance with 45 CFR 46.108(a)(3)(iii) and 21 CFR 56.108(b)a)(4) where necessary to eliminate apparent immediate hazards to human subjects or provide the subject/LAR with critical information that is vital to the subject’s continued participation in the research in accordance with HRPP policy 2.4 (IRB Review of Changes in Previously Approved Research).

      • 5.17.1. AnyThe PI will ensure that any change to the research, which is made to eliminate immediate hazards to subjects without prior IRB approval, shall be reported promptly to the IRB in accordance with HRPP policy 2.4 (IRB Review of Changes in Previously Approved Research).

    • 5.18. The PI is responsible for informing all studyresearch personnel and participating sites (as applicable) of IRB approved modifications in the protocol, IRB application, and/or consent form.

    • 5.19. The PI will ensure that when some or all of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect the rights and welfare of these subjects in accordance with HRPP policy 4.1 (Additional Protections for Vulnerable Populations)Persons).

    • 5.20. The PI is ultimately responsible for ensuring that legally effective informed consent is developed, obtained and documented in accordance with, and to the extent required byby, 45 CFR 46.116, 45 CFR 46.117, 21 CFR 50 (as applicable) and HRPP policy 5.1 (Obtaining Informed Consent Fromfrom Research Subjects).

    • 5.21. When consent is obtained by other authorized study personnel, theThe PI will ensure thethat individualpersons is appropriately trainedauthorized to obtain valid informed consent.consent Inare addition,appropriately thetrained, PIand will exert ongoing supervision of allthe authorizedinformed studyconsent personnel.

      process.

    • 5.22. The PI will ensure that the following incidents are reported to the IRB in accordance with the applicable HRPP policies (and that all secondary investigator(s) and other studyresearch personnel promptly report such incidents to the PI the following as applicable:

      PI):
      • 5.22.1. Internal Adverse Events which are unexpected and related, or possibly related, to the study interventions, and Unanticipated Adverse Device Effects, per HRPP policy 8.1 (IRB Review of Adverse Events and Adverse Device Effects).
      • 5.22.2. Unanticipated problems involving risk to the subject or others, per HRPP policy 8.3 (IRB Review of Unanticipated Problems Involving Risk)Risk to the Subject or Others).
      • 5.22.3. Noncompliance, per HRPP policy 8.4 (Review of Noncompliance)Noncompliance Involving the PI or Study Personnel)
      • 5.22.4. Complaints, per HRPP policy 8.2 (IRB Review of Study Related Complaints)

    • 5.23. The PI will ensure that all of the incidents listed under Section 5.20 above are reported to the IRB in accordance with the applicable HRPP policies.

    • 5.24. The PI will permit and facilitate monitoring and auditing of research, at reasonable times, by the IRB,IRB/ORA, funding agencies, and other authorized federal and state regulatory agencies.

    • 5.25.24. The PI, or a qualified person(s)persons designated by the PI, shall conduct periodic audits of research records.

    • 5.26.25. The PI is responsible for theensuring accuracy, completeness, legibility, and timeliness ofthat the data recordedrecorded, presented and reportedpublished inis presentationsfactual, accurate, complete and publications about the research.

      timely.

    • 5.27.26. The PI will fulfill registration and reporting requirements of ClinicalTrials.gov in compliance with HHS regulations at 42 CFR 11 (Final Rule for Clinical Trials Registration and Results Information Submission), and the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information.

      Information, and HRPP policy 1.29 (ClinicalTrials.gov Reporting).

    • 5.28.27. The PI willis maintainresponsible for maintaining all research records after the study ends for at least seven years after the study ends, or longer as required by applicable FDA, HIPAA, state, or sponsor requirements and should take measures to prevent accidental or premature destruction of these documents.

      requirements.

    • 5.29.28. The PI is responsible for submitting continuing review reports to the IRB in accordance with the approval period specified by the IRB.IRB, Theand PIsufficiently shouldin fulfilladvance of the requirementsexpiration date to allow for continuing review in time for the IRB to carry out the review prior to the expiration date of the current IRB approval.

      expiration.

    • 5.30.29. Upon completion of the research (or prematureclosure of the study), the PI is responsible to complete and submit a Study Completion Report and carry out other procedures as described in HRPP policy 2.9 (Closure of On-Going Research).

    • 5.30. Upon completion of the research (or closure of the study), the PI willis provideresponsible the IRB with the Study Completion Report and willto provide the funding and regulatory agencies with any required reports.

      reports,

    • 5.31. Once a study has been completed or closed, the PIand must continue to honor any confidentiality protections of the data as well asand other commitments agreed to as part of the approved research.

    6.0 Responsibilities of the PI for the Conduct of PI-Initiated Multicenter Research

    • 6.1. When the Participating Sites Utilize Another IRB for Oversight of Research
      • 6.1.1. The PI will fulfill all the applicable responsibilities described in Section 5.0 above.
      • 6.1.2. The PI assumes overall responsibility for the safe and proper conduct of the research at all sites (within the Organization and external sites) in full compliance with all applicable regulations and UNMC HRPP policies.policies (as applicable).
      • 6.1.3. The PI must maintain record of all external sites, including (1) names and contact information for local PIs, and (2) copies of the external IRB approval letters and approved informed consent documents.
      • 6.3.1.4. The PI must have a process in place to coordinate and communicate issues related to the protection of human subjects to all performance sites including:including, but not limited to:
        • 6.3.1. IRB initial review
        • 6.3.2. IRB continuing review
        • 6.3.3. IRB review of amendments
        • 6.3.4. Consent requirements
        • 6.3.5. HIPAA requirements
        • 6.3.6. Information security including the confidential collection and transmission of data
        • 6.3.7. Reporting requirements for:
          • 6.3.7.1. Unanticipated problems involving risks to the subjectparticipants or others
          • 6.1.4.2. 6.3.7.2.Interim Adverse eventsresults
          • 6.1.4.3. 6.3.7.3.Modifications Noncompliance
            • to
          • the 6.3.7.4.protocol Complaints
            • or
          to informed consent documents.
      • 6.4.1.5. The PI will ensure that all externalinvestigators investigatorsat participating sites promptly report to the PI the following (as applicable):
        • 6.4.1.5.1. Adverse Events which are unexpected, related or possibly related to the research.research
        • 6.4.1.5.2. Unanticipated Adverse Device Effects
        • 6.4.1.5.3. Unanticipated problems involving risk to the subject or others
        • 6.1.5.4.4. Noncompliance
        • 6.4.1.5.5. Complaints
        • 6.4.1.5.6. Audits by sponsors, CRO’s, or by FDA, OHRP, or other federal authorities,authorities
        • 6.4.1.5.7. Study reports as required by the protocol,protocol
        • 6.4.1.5.8. Continuing review reports
        • 6.4.9. Interim results
        • 6.4.10. DSMB results
      • 6.5.1.6. The PI,PI ormust have a qualifiedprocess person(s) designated by the PI, shallto conduct periodic audits of research records maintained by external investigator(s)investigators at allparticipating sites.sites as necessary
      • 6.1.7. 6.6.The IfPI must have a process to discontinue the study immediately and notify all investigators and the IRBs of record for all sites if the PI determines the research presents an unreasonable risk to subjects, the PI will discontinue the study immediately and notifications shall be sent immediately to all investigators, the IRBs of record for all sites, the sponsor and FDA (as required).
      • 6.7. When the external performance site(s) utilize(s) their own local IRB for oversight of the research, the PI must assure:
        • 6.7.1. The IRB application identifies the external sites.
        • 6.7.2. A copy of all of the following documents from the external sites are maintained in the research records:
          • 6.7.2.1. A copy of the external IRB approval letter(s) and approved ICF(s)/information sheet(s).
          • 6.7.2.2. The external site’s FWA number (required for HHS funded research)
          • 6.7.2.3. The external site’s IRB Registration number (required for FDA registered research)
          • 6.7.2.4. The external site’s HRPP accreditation status
          subjects
      • 6.8.2. When the externalParticipating performanceSites site(s) utilize(s)Utilize the UNMC IRB for oversightOversight of research.Research
        • 6.2.1. The PI must assure:
          • 6.8.1. Compliancecomply with HRPP policy 1.3 (UNMC IRB Serving as Centralthe IRB).
          • 6.8.2. TheSingle IRB application identifies the external site(s).
          • 6.8.3. An ICF is developed for eachMultisite site deferring to UNMC IRB review.
          • 6.8.4. The research records contains:
            • 6.8.4.1. Signed copies of each signed External Investigator Assurance (XIA).
            • 6.8.4.2. A copy of each external investigator’s Curriculum Vitae (CV).
            • 6.8.4.3. Copies of all signed ICFs obtained from subjects enrolled in the research by the external investigator(s) when the UNMC IRB is the IRB of record.
            Research)

        7.0 Additional Responsibilities of the PI during the Conduct of Research under the Oversight of an External IRB

        • 7.1. The PI willmust fulfillcomply all applicable requirements of the external IRB.
        • 7.2. The PI will fulfil all applicable requirements specified inwith HRPP policy 1.4 (UNMC IRB Ceding Review to an External Central IRB), and as described in the Reliance Agreement..

        8.0 Additional Responsibilities of the PI During Conduct of FDA FDA-Regulated Research

        Note: FDA guidance regarding investigator responsibilities can be found in “Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects” (October 2009)

        • 8.1. For clinical investigations involving an investigational drug, the PI is responsible for ensuring that the conditions of applicable sections of 21 CFR 312.60, 61, 62, 64, 66, 68, and 69,312 are met:

          • 8.1.1. Ensure that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation (21 CFR 312.60).
          • 8.1.2. Ensure that informed consent is obtained in accordance with the provisions of 21 CFR 50.50 (in accordance with 21 CFR 312.60).
          • 8.1.3. Ensure control of the investigational drug in accordance with 21 CFR 312.61.
          • 8.1.4. Prepare, maintain and retain records in accordance with 21 CFR 312.62 and62, Nebraska State LawLaw, perand HRPP policy 1.17 (Retention of Research Records).
          • 8.1.5. Report to sponsor in accordance with 21 CFR 312.64.
          • 8.1.6. Assure that the IRB complies with 21 CFR 56 (in accordance with 21 CFR 312.66)
          • 8.1.7. Report to the IRB all changes in the research activity and all unanticipated problems involving risk to human subjects or others; and not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects (in accordance 21 CFR 312.66)
          • 8.1.8. Allow inspection of investigator's records and reports by FDA, in accordance with 21 CFR 312.68.
          • 8.1.9. Handle controlled substances in accordance with 21 CFR 312.69.

        • 8.2. For clinical investigations involving an investigational device the PI is responsible for ensuring that the conditions of applicable sections of 21 CFR 812.100 and 110812 are met:

          • 8.2.1. Ensure that an investigation is conducted according to the signed agreement, the investigational plan and applicable FDA regulations, for protecting the rights, safety, and welfare of subjects under the investigator’s care, and for the control of devices under investigation (21 CFR 812.100)
          • 8.2.2. Ensure that informed consent is obtained in accordance with the provisions of 21 CFR 50 (in accordance with 21 CFR 812.100).
          • 8.2.3. Not request the written informed consent of any subject to participate, and not allow any subject to participate before obtaining IRB and FDA approval (21 CFR 812.110(a)).
          • 8.2.4. Conduct the investigation in accordance with the signed agreement with the sponsor, the investigational plan, applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA (21 CFR 812.110(b))
          • 8.2.5. Permit use of the investigational device only with subjects under the investigator’s supervision (21 CFR 812.110(c)).
          • 8.2.6. Disclose financial information to sponsor, as required per 21 CFR 54 (in accordance with 21 CFR 812.110(d)).
          • 8.2.7. Dispose of remaining devices perin accordance with 21 CFR 812.110(e).

        • 8.3. For clinical investigations subject to ICH GCP the investigator is responsible for requirements of ICH E6 (Guideline for Good Clinical Practice) section 4.

          .

        • 8.4. The PI is responsible for ensuring all study personnel:

          • 8.4.1. Read and understand the information in the Investigator’s Brochure, including the potential risks and side effects of the drug or device.
          • 8.4.2. EnsureConduct that athe clinical investigation is conducted according to the signed investigatorInvestigator statementStatement for(FDA clinicalform investigations1572) ofif drugs, including biological products, or agreement for clinical investigations of medical devices,applicable, the investigational plan and otherplan, applicable FDA regulations and any conditions of approval imposed by the IRB or FDA.
          • 8.4.3. Control drugs, biological products, and devices according to FDA regulations.

        • 8.5. The PI must maintain a separate list for each study conducted by the investigator, which includes (1) names of the appropriately qualified persons to whom significant trial-related duties have been delegated.delegated, This(2) listdescription should also describeof the delegated tasks, identify(3) the training that individuals have received that qualifies them to perform delegated tasks (e.g., CV, certifications), and identify(4) the dates of involvement in the study.

        • 8.6. The PI shouldis maintain separate lists for each study conducted by the investigator.

          Note: PIs who conduct clinical investigations of drugs and devices under the FDA regulations commit themselvesresponsible to personally conduct or supervise the investigation.investigation; Whenwhen certain study-related tasks are delegated by a PI, the PI is responsible for providing adequate supervision of those to whom the tasks are delegated.

        9.0 Additional Responsibilities of a Sponsor-Investigator under an Investigator-Initiated IND

        • 9.1. When the investigator also acts as a sponsor for a clinical investigation involving an investigational drugdrug, he/sheor a combination product (defined in 21 CFR 3.2(e)), they must submit a signed assurance that he/shethey understandsunderstand and acceptsaccept his/hertheir obligations per FDA regulations (21 CFR 312)312 (see Addendum O)O in Biomedical Research OR Behavioral and Social Science Research IRB application).
        • 9.2. WhenThe the investigator also acts as a sponsor for a clinical investigation involving an investigational device, in addition to all responsibilities as investigator as above, he/shePI is also responsible for ensuring that the followingconditions regulatoryof obligationsapplicable sections of 21 CFR 312 are met:
          • 9.2.1. General responsibilities, including select qualified investigators, provide them with the information they need to conduct an investigation properly, ensure proper monitoring of the investigation(s), ensure that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND, maintain an effective IND with respect to the investigations, and ensure that FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug (21 CFR 312.50).
          • 9.2.2. Select qualified investigators and monitors, who make the required assurances and commitments asin peraccordance with 21 CFR 312.53.
          • 9.2.3. Keep each participating investigator informed of new observations discovered by or reported to the sponsor on the drug, particularly with respect to adverse effects and safe use, asin peraccordance with 21 CFR 312.55.
          • 9.2.4. Monitor the progress of the clinical investigation (21 CFR 312.56)
          • 9.2.5. Monitor the compliance of investigators and respond accordingly, including ending the investigator’s participation in the clinical investigation, in accordance with 21 CFR 312.56.
          • 9.2.6. Review and evaluate the evidence relating to the safety and effectiveness of the drug, and make reports to the FDA regarding the safety of the drug and the progress of the investigation (21 CFR 312.5656)
          • 9.2.7. Discontinue the investigation if he/shethey determinesdetermine that the investigational drug presents an unreasonable and significant risk to subjects, and notify FDA, all institutional review boards, and all investigators, and assure the disposition of all stocks of the drug outstanding (21 CFR 312.56)
          • 9.2.8. Maintain and retain adequate records as described in 21 CFR 312.57, and allow FDA access to such records, asin peraccordance with 21 CFR 312.58.
          • 9.2.9. Handle controlled substances in accordance with 21 CFR 312.59.
        • 9.3. The PI shall ensure there is on-going review and evaluation of evidence relating to the safety and effectiveness of the drug,drug or combination product, and report such evaluation to (a) FDA in accordance with 21 CFR 312.33, and (b) the UNMC IRB when there is a safety concern.
        • 9.4. If the PI determines the investigational drug presents an unreasonable risk to subjects, the PI will discontinue the study immediately and notifications shall be sent immediately to all externalinvestigators investigators,(including investigators at all participating sites), the IRBs of record for all sitessites, and FDA.FDA (in accordance with 21 CFR 312.50).

        10.0 Additional Responsibilities of a Sponsor-Investigator under an Investigator-Initiated IDE

        • 10.1. When the investigator also acts as a sponsor for a clinical investigatorinvestigation involving an investigational device he/shethey must submit a signed assurance that he/shethey understandsunderstand and acceptsaccept his/hertheir obligations per FDA regulations (21 CFR 812) (see Addendum P)P in Biomedical Research OR Behavioral and Social Science Research IRB application).
        • 10.2. When the investigator also acts as a sponsor for a clinical investigator involving an investigational device, in addition to all responsibilities as investigator as above, he/shethey isare also responsible for ensuring that the followingconditions regulatoryof obligationsapplicable sections of 21 CFR 812 are met:
          • 10.2.1. General Duties (21 CFR 812.40), including submitting an IDE to the FDA in accordance with the requirements of 21 CFR 812.20.
          • 10.2.2. Selection of Investigators (21 CFR 812.43)
          • 10.2.3. Monitoring (21 CFR 812.46)
          • 10.2.4. Controlling Distribution and Disposition of Devices. The sponsor-investigator must take proper measures to ensure that devices are not diverted outside of legally authorized channels, may ship investigational devices only to qualified investigators participating in the clinical investigation (21 CFR 812.43(b)), must maintain complete, current, and accurate records pertaining to the shipment and disposition of the investigational device (21 CFR 812.140(b)), take appropriate measures to instruct investigators regarding their responsibilities with respect to recordkeeping and device disposition per 21 CFR 812.140(a).
          • 10.2.5. Prohibition of Promotion and Other Practices (21 CFR 812.7)
          • 10.2.6. Supplemental Applications [(21 CFR 812.35(a) and (b)])
          • 10.2.7. Maintaining Records [(21 CFR 812.140(b)])
          • 10.2.8. Submitting Reports [(21 CFR 812.150(b)])
          • 10.2.9. Inspections [(21 CFR 812.145]145)
        • 10.3. The PI shall ensure there is on-going review and evaluation of evidence relating to the safety and effectiveness of the device and report such evaluation to (a) FDA, and (b) the UNMC IRB when there is a safety concern.
        • 10.4. If the PI determines the investigational device presents an unreasonable risk to subjects, the PI will discontinue the study immediately and notifications shall be sent immediately to all investigators (including investigators at all participating in the research,sites), the IRBs of record for all sites, and FDA, in accordance with 21 CFR 812.45.

        DOCUMENT HISTORY:

         Written: 5/6/2016 (Approved: 5/6/2016) - original author not recorded

         Revised: 9/27/2017 - revision not documented

         Revised: 3/3/2018 - revision not documented

         Revised: 9/5/2018 - revision not documented

         Revised: 10/11/2019 - revision not documented

         Revised: 12/10/2019 - revision not documented

         Revised: 6/27/2022 - "Clarification of definition of "volunteer faculty; inclusion of emeritus faculty; inclusion of individuals operating under a special memorandum of understanding; clarification of requirement that volunteer conducting research with direct subject contact be present physically on campus, or have UNMC co-investigator physically on campus; faculty".

         Revised 6/11/2025 - Revised definitions of investigators; removed or modified references to medical licensure as appropriate; deleted duplicated information from multiple sections; clarified scope of policy regarding research conducted at other sites relying on UNMC IRB; deleted reference to External Investigators and External Investigator Agreements; clarified PI Qualifications (section 4.0); clarified qualifications and responsibilities of student PIs and Faculty advisors; deleted requirement that PI retain written documentation of IRB approval or exempt determination; clarified responsibilities of PI when the participating sites utilize another IRB for oversight of research or when the participating sites utilize the UNMC IRB for oversight of research; revised PI responsibilities when acting as sponsor-investigator of a clinical investigation involving a combination product; simplified multiple sections related to PI responsibilities; simplified regulatory citations; stylistic changes.

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